MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. IMPRESS ANGIOGRAPHIC CATHETER

Catalog Number	410038VER
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a peripheral vascular stent placement procedure, the catheter tip detached within the patient's common iliac artery [cia].The physician had acquired retrograde femoral artery access and had successfully placed the stent within the patient's common iliac artery [cia].While attempting to remove the catheter over the super stiff guidewire, the physician felt the catheter tip detach but it remained on the guidewire.The guidewire was withdrawn to the femoral artery and the physician proceeded with a cutdown procedure to remove the catheter tip.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint is confirmed.No definitive root cause could be determined however, it is likely that excessive force was applied to the device.A review of the complaint database was performed and no similar complaints for this lot number were found.A review of the device history record was performed and no exception documents were found.

• Brand Name: IMPRESS ANGIOGRAPHIC CATHETER
• Common Device Name: ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston 77047
• MDR Report Key: 6849604
• Report Number: 3010665433-2017-00058
• Device Sequence Number: 1124599
• Product Code: DQO
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K053171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 410038VER
• Device Lot Number: E938155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/28/2017
• Supplement Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK LUNDERQUIST WIRE; GORE 22F INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Required Intervention